A Single Ascending Dose Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of RO6836191 in Healthy Male Volunteers.
Phase 1
Completed
- Conditions
- Atherosclerosis
- Interventions
- Other: NS followed by LS diet conditionOther: LS followed by NS diet conditionDrug: RO6836191Drug: Placebo
- Registration Number
- NCT01995383
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single-center, randomized, placebo-controlled, double-blind study will assess the safety, pharmacokinetics and pharmacodynamics of RO6836191 in healthy male volunteers in two parts. Part 1 will assess the safety of oral single ascending doses of RO6836191 compared to placebo in fasted volunteers. In Part 2, participants will be given two single oral doses of RO6836191 or placebo under low or normal-salt diet conditions. A subset of these participants will subsequently receive a single IV dose of RO6836191 for further analysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 88
Inclusion Criteria
- Healthy male volunteers, aged 18 to 45 years old.
- No active or chronic disease following a detailed medical and surgical history and complete physical examination.
- A BMI between 18 to 30 kg/m2 inclusive.
- Use of a highly effective form of birth control for the duration of the study and until 90 days after the last dose.
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Exclusion Criteria
- Any clinically relevant current or history of conditions or illnesses.
- Clinically significant symptoms of infection within 5 days of the first dosing day or a history of recurrent infections.
- Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse.
- Smokers unable or unwilling to restrict to 5 cigarettes daily during the study and to not smoke during the stay at the clinic.
- Any cardiac abnormalities.
- Blood donation over 450 mL within three months prior to screening.
- Participation in an investigational drug or device study within 3 months prior to dosing.
- Corticosteroid use within 3 months prior to dosing.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 2: RO6836191: NS followed by LS diet NS followed by LS diet condition - Part 2: RO6836191: NS followed by LS diet RO6836191 - Part 2: PL: Low-salt (LS) followed by normal-salt (NS) diet RO6836191 - Part 2: PL: Low-salt (LS) followed by normal-salt (NS) diet LS followed by NS diet condition - Part 2: PL: NS followed by LS diet Placebo - Part 2: PL: NS followed by LS diet RO6836191 - Part 2: PL: NS followed by LS diet NS followed by LS diet condition - Part 1: Placebo (PL) Placebo - Part 1: Single Ascending Doses (SAD) of RO6836191 RO6836191 - Part 2: RO6836191: LS followed by NS diet RO6836191 - Part 2: PL: Low-salt (LS) followed by normal-salt (NS) diet Placebo - Part 2: RO6836191: LS followed by NS diet LS followed by NS diet condition -
- Primary Outcome Measures
Name Time Method Part 1: Urine aldosterone levels Up to Day 3 Part 1: Plasma aldosterone levels Up to Day 5 Part 2: Urine aldosterone levels Up to 3 days after drug administration Part 2: Incidence of AEs Up to 12 weeks Parts 1: Incidence of adverse events (AE) Until Day 21 Part 2: Area under the concentration-time curve (AUC) Up to Day 35 Part 2: Plasma aldosterone levels Up to 2 days after drug administration
- Secondary Outcome Measures
Name Time Method Part 2: Volume of distribution after intravenous administration Days 28-37